Overview

This trial is active, not recruiting.

Conditions behavior disturbance, muscle hypotonia
Treatments multisensory environment (mse), massage therapy (mt), control group, massage therapy in multisensory environment (mt-mse)
Sponsor The Hong Kong Polytechnic University
Start date April 2013
End date November 2016
Trial size 240 participants
Trial identifier NCT02120820, HongKongPU

Summary

The aim of this study is to evaluate the effectiveness of multisensory environment (MSE) and/or massage therapy (MT) in residents with severe and profound intellectual disabilities (ID) who received massage therapy in MSE, activities in MSE alone, massage therapy in usual care environment, or usual care with attention.

Since there has not yet been any conclusive evidence to show the clinical efficacy of MT and MSE on relaxation and reducing challenging behaviours, the following null hypotheses are suggested:

1. There will not be any differences on reducing heart and respiration rates between MT-MSE, MT, MSE, and usual care only over the 10-week intervention period and a 2-week follow-up.

2. There will not be any differences on adaptive behaviours and levels of alertness between MT-MSE, MT, MSE, and control group over the 10-week intervention period and a 2-week follow-up.

3. There will not be any differences on frequency and severity of challenging behaviours between MT-MSE, MT, MSE, and control group over the 10-week intervention period and a 2-week follow-up.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose health services research
Arm
(Active Comparator)
Multisensory environment (MSE): 30 minutes/session, twice a week for 10 weeks
multisensory environment (mse) Sensory stimulation
Participants are staying in multisensory environment (MSE only) for 30 minutes in each session, and twice per week for 10 weeks. An enabler stays with the participant throughout the session.
(Active Comparator)
Massage therapy (MT): 15 minutes/session, twice a week for 10 weeks
massage therapy (mt) Massage
A trained massage therapist provides 15 minutes massage therapy (MT) to the participants, twice a week for 10 weeks. The massage therapist acts as an enabler.
(Other)
Control group: usual care for 10 weeks, with attention and interactions with the caregivers only.
control group Placebo
Usual residential care will be given to these participants. Only attention and social interactions from the enabler will be provided.
(Active Comparator)
Participants receive 15 minutes massage therapy in multisensory environment (MT-MSE), twice a week for 10 weeks.
multisensory environment (mse) Sensory stimulation
Participants are staying in multisensory environment (MSE only) for 30 minutes in each session, and twice per week for 10 weeks. An enabler stays with the participant throughout the session.
massage therapy (mt) Massage
A trained massage therapist provides 15 minutes massage therapy (MT) to the participants, twice a week for 10 weeks. The massage therapist acts as an enabler.
massage therapy in multisensory environment (mt-mse) Massage
Participants receive 15 minutes massage therapy while staying in multisensory environment for 30 minutes, twice a week for 10 weeks.

Primary Outcomes

Measure
Behavior Problem Inventory (BPI-01): frequency and severity of challenging behaviours
time frame: Baseline (at recruitment)
Behavior Problem Inventory (BPI-01)
time frame: 5 weeks after intervention started (interim assessment)
Behavior Problem Inventory (BPI-01)
time frame: 10 weeks after intervention started (Post-test 1)
Behavior Problem Inventory (BPI-01)
time frame: 12 weeks after intervention started (Post-test 2)
Respiration and Pulse Rate
time frame: Baseline (at recruitment)
Respiration and Pulse Rate
time frame: 5 weeks after intervention started (interim assessment)
Respiration and Pulse Rate
time frame: 10 weeks after intervention started (Post-test 1)
Respiration and Pulse Rate
time frame: 12 weeks after intervention started (Post-test 2)

Secondary Outcomes

Measure
Alertness Observation Checklist (AOC)
time frame: Baseline (At recruitment)
Alertness Observation Checklist (AOC)
time frame: 5 weeks after intervention started (interim assessment)
Alertness Observation Checklist (AOC)
time frame: 10 weeks after intervention started (Post-test 1)
Alertness Observation Checklist (AOC)
time frame: 12 weeks after intervention started (Post-test 2)
Behaviour Checklist (BC)
time frame: Baseline (at recruitment)
Behaviour Checklist (BC)
time frame: 5 weeks after intervention started (interim assessment)
Behaviour Checklist (BC)
time frame: 10 weeks after intervention started (Post-test 1)
Behaviour Checklist (BC)
time frame: 12 weeks after intervention started (Post-test 2)

Eligibility Criteria

Male or female participants from 18 years up to 64 years old.

Inclusion Criteria: - exhibiting at least one type of challenging behavior - admitted at least 3 months for long-term care - being dependent on nursing care and physical assistance in daily activities - aged 18 to 64 years Exclusion Criteria: - seriously ill or completely bed-rest residents - having infectious diseases - frequently discharged to general hospital for acute care - frequent home or day leave - having pressure ulcer and/or severe contracture and deformity - being restless and reluctant to stay in multisensory environment, or receive massage therapy

Additional Information

Official title An Evaluation of the Clinical Efficacy of Massage Therapy in a Multisensory Environment for Residents With Severe and Profound Intellectual Disabilities
Principal investigator Wai Tong CHIEN, PhD
Description Design: This study adopts a mixed methods research design, in which both quantitative (i.e., randomized controlled trial design) and qualitative (exploratory) approaches will be used. Methods: After the study criteria are checked and met and proxy consent has been obtained, the participants will undergo a period of washout (4 weeks) from the current multisensory environment (MSE) and/or massage therapy (MT) sessions. After that, the baseline measurement of all outcome measures will be taken. All of them will then be randomly assigned to one of the four study groups, including three treatment groups, namely massage therapy in MSE (MT-MSE), MSE only and massage therapy in usual care environment (MT), and one control (routine care) group. The effects of the three proposed interventions and routine care only groups on the study outcomes, including frequency and severity of challenging behaviour, adaptive behaviour, alertness level, and heart and respiration rate, will be compared between groups at baseline, interim (i.e., 5 weeks after the interventions started), immediately after completion of the interventions (i.e. 10 weeks after the interventions started), and 2 weeks follow up (i.e. at 12 weeks from the start of intervention, but no intervention at week 11 and 12). A pilot study will be conducted to review the feasibility and clarity of the study procedure, intervention protocols, and outcome measurements in around 30 patients with similar clinical characteristics (i.e., 8 subjects per groups) before starting the main study. Primary outcomes of the study are frequency and severity of challenging behaviours, and the physiological signs (i.e., respiration and pulse rate). The secondary outcomes are the levels of alertness and adaptive behaviours. Primary nurses who are responsible to formulate the individualized MSE and/or MT programs of the participants in the three treatment groups will be invited to participate a face-to-face semi-structured interview in order to explore their perceptions and opinions towards the strengths and limitations of the intervention(s) used, factors influencing the challenging behaviours of the disabled residents, and their suggested strategies in reducing their clients' challenging behaviours in their work setting.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by The Hong Kong Polytechnic University.